BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3602379 · Received January 31, 2014

    Report

    Report Number
    2955842-2014-00567
    Event Type
    Other
    Date Received
    January 31, 2014
    Date of Event
    January 2, 2014
    Report Date
    January 2, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAMERA HEAD WAS RETURNED TO ISI AND EVALUATED. THE REPORTED CUSTOMER FAILURE MODE WAS REPLICATED WITH THE FAILURE ANALYSIS (FA) OF THE CAMERA HEAD. ACCORDING TO THE FA, THE CAMERA HEAD WAS FOUND TO HAVE A DAMAGED FOCUS STAGE ASSEMBLY THAT WAS CAUSED BY MECHANICAL SHOCK. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: PER THE CONSENT OF THE PATIENT'S SPOUSE, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI PROSTATECTOMY PROCEDURE TO OPEN SURGICAL TECHNIQUES AFTER THE SURGICAL STAFF ENCOUNTERED A 3D VISION ISSUE WITH THE SSC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY PROCEDURE, THE SURGEON INDICATED THAT THE SURGEON SIDE CONSOLE (SSC) DID NOT HAVE A 3D IMAGE. DURING THE EVENT, THE SURGICAL STAFF CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE. THE SURGICAL STAFF TURNED ON THE COLOR BAR IN THE RIGHT EYE OF THE SSC, CHANGED THE CAMERA CABLE AT THE CAMERA CONTROL UNIT (CCU), AND POWER CYCLED THE SYSTEM. HOWEVER, THE REPORTED VISION ISSUE PERSISTED. THE SYSTEM WAS REPAIRED BY REPLACING THE CAMERA HEAD AND CABLE. ON (B)(4) 2014, ISI CONTACTED THE CSR. THE CSR INDICATED THAT THE SURGEON NOTICED THE 3D VISION ISSUE AFTER THE PATIENT SIDE CART (PSC) WAS DOCKED TO THE PATIENT AND WHEN HE FIRST SAT DOWN AT THE SSC AND LOOKED THROUGH THE HIGH RESOLUTION STEREO VIEWER (HRSV). DUE TO THE VISION ISSUE, THE SURGEON PLANNED ON ABORTING AND RESCHEDULING THE DA VINCI PROSTATECTOMY PROCEDURE. HOWEVER, AFTER THE SURGEON CONSULTED WITH THE PATIENT'S SPOUSE, THE SURGEON MADE THE DECISION TO PROCEED WITH THE PROSTATECTOMY PROCEDURE PER THE CONSENT OF THE PATIENT'S SPOUSE VIA OPEN SURGICAL TECHNIQUES. ACCORDING TO THE CSR, THE OPEN SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67635 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other